EscharEx (EX-02) for small superficial and nodular basal cell carcinoma.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label, one-arm study will enroll 32 adults with a single histologically confirmed superficial or nodular basal cell carcinoma (5–10 mm) on the trunk or upper extremities. All participants will receive topical EscharEx (EX-02) 5% in two sequential cohorts (first 16 patients for initial safety review, then 16 additional patients) with frequent clinic visits during the treatment period. Patients will undergo complete surgical excision about eight weeks after treatment and will be followed until biopsy confirms tumor clearance and the wound has closed. Safety monitoring includes sponsor review and oversight by a DSMB, and primary endpoints include safety and histologic lesion clearance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Inclusion Criteria- Patient level

1. Male or female greater than age 18,
2. Patients with one primary superficial or nodular basal cell carcinoma lesion (Histologically confirmed BCC) located on the trunk or upper extremities (not including the hands), with well-defined borders and no previous radiation therapy.
3. Lesion is present for no longer than 4 years.
4. Lesion with a diameter of 5-10mm,
5. Patient and/or legally authorized representative (LAR) understands the nature of the procedure, is able and willing to adhere to the protocol regimen, and able to provide a written informed consent prior to any study procedure.

Exclusion Criteria:

Exclusion Criteria- Patient level

1. Evidence of Gorlin syndrome, neoplastic diseases (except actinic lesions), metastatic tumor or tumor with high probability of metastatic spread,
2. Other malignant cancers (non BCC) of the skin at the lesion's site,
3. Morphea-type basal cell carcinoma (MBCC) at the lesion's site (per biopsy report),
4. Any signs of infection at the lesion site including purulent discharge, tissue abscess, erysipelas, cellulitis, etc.,
5. Patients with any dermatological disease in the target lesion site or surrounding area (not including chronic actinic damage in the surrounding area),
6. History of allergy or atopic disease or a known sensitivity to pineapples, papaya, bromelain or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen,
7. Patients undergoing renal or peritoneal dialysis,
8. Any condition that would preclude safe participation in the study, e.g. evidence of significant or unstable cardiovascular, pulmonary, liver, hematological, immunological, or any immediate life threatening condition,
9. Concurrent acute injury or disease that might compromise the patient's welfare or the participation in the study,
10. Current (within last 12 months) severe alcohol or drug use disorder
11. Pregnant women (positive blood or urine pregnancy test) or nursing mothers,
12. Exposure to investigational intervention within 4 weeks prior to enrolment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.

Where it's running

• Center for Clinical and Cosmetic Research
  Aventura, Florida, United States Recruiting
• Center for Clinical Studies, LTD. LLP
  Webster, Texas, United States Recruiting
• Moore Clinical Research, Inc.
  Brandon, Florida, United States Not yet recruiting

Study contacts

• Study coordinator: Limor Dinur Klein, PhD
• Email: limord@mediwound.com
• Phone: 972779714000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.